Neurosurgery 96:751–762, 2025
The INSPIRE 2.0 trial evaluated the safety and efficacy of a bioresorbable polymer scaffold for treating thoracic spinal cord injury. The study concluded that the scaffold did not provide a probable clinical benefit, leading to the trial’s early termination due to lack of efficacy and funding issues.
• The study INSPIRE 2.0 assessed the safety and potential benefit of a bioresorbable polymer scaffold (Neuro-Spinal Scaffold) in patients with complete thoracic spinal cord injury (SCI).
• Conducted as a randomized controlled trial at Level I trauma centers in the U.S., the study compared NSS implantation with standard-of-care spine surgery.
• The primary endpoint was the proportion of patients with an improvement of ≥1 AIS grade at 6 months post-surgery.
• Results showed no significant benefit of NSS over standard surgery; 20% of NSS patients improved compared to 30% of control patients.
• The study was terminated early due to not meeting its primary endpoint and subsequent withdrawal of industry sponsorship.
• Safety events were mostly mild or moderate, with no serious adverse device effects reported.
• The study highlighted the challenges of conducting clinical trials on spinal cord injury and the importance of reporting negative results.
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